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- Ensayo clínico NCT02467920
Efficacy and Safety of Basal Insulin Glargine Combination With Exenatide Bid vs Aspart30 in T2DM
Efficacy and Safety of Basal Insulin Glargine Combination With Exenatide Bid vs Switching Premix Human Insulin to Aspart30 in T2DM With Inadequate Glycaemic Control on Premixed Human Insulin and Metformin: a Randomized, Open, Parallel Trial
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
This is a multicentre, open-label, randomized and parallel trial that will compare the efficacy and safety of basal insulin glargine combination with Exenatide bid vs. switching premix human insulin to aspart30 in type 2 diabetic patients with inadequate glycaemic control on premixed human insulin and metformin. Approximately 248 patients will be enrolled in the study from China and randomized in a 1:1 ratio to one of the 2 treatment arms: once-daily insulin glargine + twice-daily exenatide + metformin; or twice-daily aspart 30 + metformin.
Study treatment will continue for 24 weeks. The primary efficacy measure is the change in HbA1c at 24 weeks. The study consists of 3 periods: a 1-week screening (period A), a 12-week run-in period (period B) and a 24-week treatment period (period C).
Tipo de estudio
Inscripción (Actual)
Fase
- Fase 4
Contactos y Ubicaciones
Ubicaciones de estudio
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Hubei
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Wuhan, Hubei, Porcelana, 430000
- Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- Provision of informed consent
- Type 2 diabetic patients receiving twice-daily premixed human insulin 30 therapy ≥ 30 U/d and metformin with maximum tolerated dosage (≤ 1500mg/d)
- HbA1c > 8.0 % and < 11.0 % (HbA1c > 7.0 % and < 10.0% at randomization)
- Men and women (non-pregnant and using a medically approved birth-control method) aged ≥ 18 and ≤ 70 years
- BMI ≥ 23 and ≤ 35 kg/m2
Exclusion Criteria:
- Type 1 diabetes or other specific types of diabetes
- Pregnancy, preparation for pregnancy, lactation and women of child-bearing age incapable of effective contraception methods
- Uncooperative subject because of various reasons
- Abnormal liver function, glutamic-pyruvic transaminase (ALT) and glutamic-oxaloacetic transaminase (AST) > twice the upper limits of normal
- Impairment of renal function, serum creatinine: ≥ 133mmol/L for female,≥ 135mmol/L for male
- Serious chronic gastrointestinal diseases
- Edema
- Serious heart diseases, such as cardiac insufficiency (level III or more according to NYHA), acute coronary syndrome and old myocardial infraction
- Blood pressure: Systolic blood pressure (SBP) ≥ 180mmHg and/or diastolic blood pressure (DBP) ≥ 110mmHg
- White blood count (WBC) < 4.0×109/L or platelet count (PLT) < 90×109/L,or definite anemia (Hb:< 120g/L for male, < 110g/L for female), or other hematological diseases
- Endocrine system diseases, such as hyperthyroidism and hypercortisolism
- Experimental drug allergy or frequent hypoglycemia
- Psychiatric disorders, drug or other substance abuse
- Diabetic ketoacidosis and hyperosmolar nonketotic coma requiring insulin therapy
- Stressful situations such as surgery, serious trauma and so on
- Chronic hypoxic diseases such as pulmonary emphysema and pulmonary heart disease
- Combined use of drugs effecting glucose metabolism such as glucocorticoid
- Tumor, especially bladder tumor and/or family history of bladder tumor and/or long-term hematuria
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
---|---|
Experimental: glargine + exenatide
Type 2 diabetic patients with inadequate glycaemic control on premixed human insulin and metformin previously.
After a 12-week run-in period , switching premix human insulin to glargine ( once-daily subcutaneous injection at bedtime) combination with exenatide (subcutaneous injection, twice-daily).
|
glargine ( once-daily subcutaneous injection at bedtime) combination with exenatide (subcutaneous injection, twice-daily)
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Comparador activo: aspart 30
Type 2 diabetic patients with inadequate glycaemic control on premixed human insulin and metformin previously.
After a 12-week run-in period , switching premix human insulin to aspart 30 ( subcutaneous injection, twice daily).
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aspart 30 ( subcutaneous injection, twice daily)
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
---|---|
the absolute change in HbA1c from baseline to 24-week endpoint of basal insulin glargine combination with exenatide bid vs. switching to aspart30 in type 2 diabetic patients inadequately controlled on premixed human insulin and metformin.
Periodo de tiempo: from baseline to 24-week endpoint
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from baseline to 24-week endpoint
|
Medidas de resultado secundarias
Medida de resultado |
Periodo de tiempo |
---|---|
Change in HbA1c from baseline to 12 weeks endpoint
Periodo de tiempo: from baseline to 12 weeks endpoint
|
from baseline to 12 weeks endpoint
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The percentage of participants who achieved HbA1c ≤ 6.5% and < 7%
Periodo de tiempo: 12 weeks and 24 weeks
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12 weeks and 24 weeks
|
Fasting blood glucose
Periodo de tiempo: 12 weeks and 24 weeks
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12 weeks and 24 weeks
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Daily insulin use
Periodo de tiempo: baseline, 12 weeks and 24 weeks
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baseline, 12 weeks and 24 weeks
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Change in body weight
Periodo de tiempo: from baseline to 12 and 24 weeks
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from baseline to 12 and 24 weeks
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The incidence and rate of hypoglycaemic events during the study
Periodo de tiempo: baseline, 12 weeks and 24 weeks
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baseline, 12 weeks and 24 weeks
|
Colaboradores e Investigadores
Patrocinador
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
- Trastornos del metabolismo de la glucosa
- Enfermedades metabólicas
- Enfermedades del sistema endocrino
- Diabetes mellitus
- Diabetes Mellitus, Tipo 2
- Agentes hipoglucemiantes
- Efectos fisiológicos de las drogas
- Hormonas
- Hormonas, sustitutos hormonales y antagonistas hormonales
- Agentes contra la obesidad
- Incretinas
- Exenatida
Otros números de identificación del estudio
- ESR-14-10352
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .
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